An agency of the European Union

ESVAC (European Surveillance of Veterinary Antimicrobial Consumption)

Present and future activities

60th Meeting of the EFSA advisory forum

Presented J. Torren, Scientific Administrator, Animal and Public Health, Veterinary Medicines

Department on 8 June 2016

Content of the presentation

• History

• Objectives

• Method

• Results

• Caveats of the ESVAC project

• Future activities

• Conclusions

ESVAC 1

European Commission request to EMA on collecting consumption data

To develop harmonised approach for collection and reporting of data on use of antimicrobial agents based on national sales figures, as well as estimates on consumption in at least the major groups of animal species.

Fifth report of the ESVAC series, all the reports available from: www.ema.europa.eu

ESVAC 2

Intended use of surveillance data on antimicrobial consumption: .

• To aid interpretation of patterns and trends regarding antimicrobial resistance (AMR);

• As input to risk profiling and risk assessment regarding AMR;

• For setting risk management priorities;

• To evaluate the effectiveness of measures being implemented to promote prudent use;

• To identify changing patterns of use of veterinary antimicrobial agents;

• To aid comparison of use of veterinary antimicrobial agents between human and veterinary medicine, time periods and countries;

• As a basis for focused and targeted research and development.

3 ESVAC

The ESVAC technical approach

Data sets

• Sales data provided at package level (name, pharmaceutical from, pack size ingredient(s) and strength(s). Calculated to express tonnes of active ingredient

• Animal population data from Eurostat, TRACES and national (horses).

The main indicator applied to express the consumption of veterinary antimicrobials is mg active ingredient normalised by the population correction unit (mg/PCU):

Amount sold in metric tonnes × 109

PCU in kg

4 ESVAC

ESVAC indicators

The ESVAC main indicator is:

• mg active ingredient sold per population correction unit — mg/PCU.

Other indicators:

Tonnes sold for food producing species, of the various antimicrobial veterinary

classes, per country, per year (Table A1).

Sales for food producing species, in milligrams active substance per Population

Correction Unit (mg/PCU), of the various antimicrobial veterinary classes, per

country, per year. (Figure 9).

Sales for food producing species, in milligrams active substance per Population

Correction Unit (mg/PCU), by form, per country, per year (Fig 7).

* Refers to the 2013 ESVAC report figures and tables

ESVAC 5

ESVAC indicators (cont.)

Changes in sales (mg/PCU) for the

countries and years for which data

are available.

ESVAC 6

Results: Sales for food-producing species, including horses, in mg/PCU,

of the various veterinary antimicrobial classes, for 26 countries, in 2013

7

Differences likely to be partially due to differences in the composition of the animal population in the various countries

ESVAC

Spatial distribution of overall sales of all antimicrobials for

food-producing animals, in mg/PCU, for 26 countries, for 2013

8 ESVAC

Changes by 23 EU/EEA countries, 2011-2013

9

Percentage changes in PCU, in tonnes sold and in sales of veterinary antimicrobial agents for food-producing species, including horses, in mg/PCU, from 2011 to 2013, aggregated by 23 EU/EEA countries

-2.8% -10.5%

-7.9%

-15%

-10%

-5%

0%

5%

10%

PCU Tonnes sold mg/PCU

ESVAC

Distribution of sales, in mg/PCU, of the various pharmaceutical forms of veterinary

antimicrobial agents for food-producing animals, including horses, aggregated by the 26

EU/EEA countries for 2013

10 ESVAC

Sales of antimicrobial agents by antimicrobial class as percentage of the total

sales for food-producing species, including horses, in mg/PCU, aggregated by 26

countries, for 2013

11 ESVAC

Caveats of the ESVAC data

• It takes at least three to four years in order to establish a

valid baseline for the data on sales of veterinary antimicrobial

agents.

• Data provided at package level, but not by animal species.

• Data reported as tonnes.

• 80% of the data are provided by the pharmaceutical industry.

• Heterogeneous source of data (pharmaceutical industry,

wholesalers, pharmacies, prescription data).

• No benchmarking within the country.

• Data from Greece and Malta missing.

12 ESVAC

Animal and

Public Health

AWP Antimicrobial Working Party

Expert Groups

AMEG Antimicrobial Advice ad hoc Expert Group

JIACRA Joint Interagency Antimicrobial Consumption and Resistance

RONAFA Reduction of the Need of Antimicrobials in Food Producing Animals

TATFAR Trans-Atlantic Task Force on Antimicrobial Resistance

ESVAC European Surveillance of Veterinary

Antimicrobial Consumption

Sales

Advisory Group

Species

Advisory Group

Use antimicrobials

Stratification

Units of Measurement

Advisory Group ESVAC 13

Future of ESVAC project

• Overall sales data will continue in the future.

• EC review of legislation likely to require antimicrobial consumption data per species

from Member States.

• Consumption data per species is resource demanding and requires time and

experience.

• ESVAC dedicating careful considerations on how to achieve systems at national level

that are comparable at international (EU) level.

• Automated collection of continuous data will facilitate the collection of such data,

but it will take years to be implemented in the EU.

• Complementary systems (stratification) will be explored by ESVAC.

• DDDvet and DCDvet now published. 14 ESVAC

Conclusions of ESVAC

15

• Until now we have observed a reduction on antimicrobial use in the EU/EEA.

• Considerable heterogeneity on the trends of antimicrobial use is observed.

• The overall reduction in sales is mainly accounted for by a few countries suggesting that

there it is a potential for reduction in the others as well.

• The sales of fluoroquinolones and 3rd- and 4th-generation cephalosporins were stable

during the period of 2010-2013.

• The most sold antimicrobials are tetracyclines, penicillins and sulfonamides administered

orally.

• Data on sales of antimicrobials are powerful tools to encourage countries to take action

on the use of antimicrobials in animals.

ESVAC

Conclusions (cont.)

ESVAC 16

• ESVAC data allows for targeted objectives.

• Reduction of use of colistin below 5 mg/PCU

• No increase in use of fluoroquinolones or

3rd and 4th generation cephalosporins

• No increase in overall antimicrobial use

Thank you for your attention

ESVAC@ema.europa.eu

European Medicines Agency

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